June, 2016 Newsletter Articles

ISO 9001:2015, 8.5

Jun 1, 2016 in Newsletter | Comments Off on ISO 9001:2015, 8.5

Clause 8, Operation, has seven sub-clauses: 8.1 Operational Planning and Control 8.2 Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of Externally Provided Processes, Products, and Services 8.5 Production and Service Provision 8.6 Release of Products and Services 8.7 Control of Nonconforming Outputs This article is on 8.5 Production and Service Provision. 8.5.1 Control of Production and Service Requirements: Implement production and service provision under controlled conditions. Include,...

Read More

ISO 13485:2016 Documents

Jun 1, 2016 in Newsletter | Comments Off on ISO 13485:2016 Documents

The recently revised medical device standard, ISO 13485:2016, requires a quality management system that includes these documents and procedures. Required Documents and Procedures (Clause) 01. Roles undertaken by organization under applicable regulatory requirements (4.1.1) 02. Procedures for validation of the application of software used in QMS (4.1.6) 03. Statement of quality policy (4.2.1.a) See 5.3. 04. Statement of quality objectives (4.2.1.a) See 5.4.1. 05. Quality manual (4.2.1.b) See 4.2.2. 06. Procedures required by the standard...

Read More

ISO 13485:2016 Records

Jun 1, 2016 in Newsletter | Comments Off on ISO 13485:2016 Records

The recently revised medical device standard, ISO 13485:2016, requires a quality management system that includes these records. Required Records (Clause) 01. Records to demonstrate conformance to standard and compliance to regulations (4.1.3.e) 02. Records of validations and revalidations of application of software used in QMS (4.1.6) 03. Records required by the standard (4.2.1.c) 04. Records necessary to ensure effective process planning, operation, and control (4.2.1.d) 05. A least one copy of obsolete documents retained for defined period...

Read More

2015 Edition Classes

Jun 1, 2016 in Newsletter | Comments Off on 2015 Edition Classes

We are offering public “ISO 9001:2015 Requirements and Transition Guidance” classes in Atlanta, GA and Orlando, FL. The course is also available as an on-site class, as is our “ISO 14001:2015 Requirements and Transition Guidance” course. ISO 9001:2015 Requirements and Transition Guidance Enrollment for our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” course is $795 and includes lunch both days. August 3-4, 2016 in Atlanta, GA SpringHill Suites – Atlanta Airport Gateway 2091 Convention...

Read More

Risk Management

Jun 1, 2016 in Newsletter | Comments Off on Risk Management

Risk Management According to ISO 31000, “Risk management – Principles and guidelines”, organizations of all types and sizes face internal and external factors and influences that make it uncertain whether and when they will achieve their objectives. The effect this uncertainty has on an organization’s objectives is “risk”. All activities of an organization involve risk. Organizations manage risk by identifying it, analyzing it, and then evaluating whether the risk should be modified by risk treatment in...

Read More

Gap Checklists

Jun 1, 2016 in Newsletter | Comments Off on Gap Checklists

Larry Whittington has developed ISO 9001:2015 and ISO 14001:2015 checklists for the purpose of conducting a gap analysis of your current system against the new and changed requirement of the new standards. ISO 9001:2015 Gap Analysis Checklist The 27 page ISO 9001:2015 Gap Analysis Checklist contains 313 questions for organizations new to ISO 9001, and 119 delta questions for ISO 9001:2008 certified organizations. To read a description of the ISO 9001:2015 Gap Analysis Checklist, and see a sample page, go to this web page. You can buy the...

Read More